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| Certification Vendor: | PECB |
|---|---|
| Exam Name: | QMS ISO 9001:2015 Lead Auditor Exam |
| Exam Number: | ISO-9001-Lead-Auditor |
| Available Languages: | Italian, French, English, Portuguese, German, Russian, Chinese, Spanish, Arabic |
| Exam Price: | $1000 USD |
| Related Certifications: | ISO 9001 Auditor ISO 9001 Provisional Auditor ISO 9001 Foundation |
| Exam Format: | Multiple choice, Scenario-based, Multi-response, Open-book |
| Real Exam Qty: | 40–80 |
| Exam Duration: | 180 (120 + 30 for non-native speakers) |
| Passing Score: | 70% (minimum 28/40 or 56/80 correct answers) |
| Certificate Validity Period: | 3 years |
| Recommended Training: | PECB ISO 9001 Lead Auditor Training Course |
| Exam Registration: | PECB Official Registration |
| Sample Questions: | PECB ISO-9001-Lead-Auditor Sample Questions |
| Exam Way: | Online proctored via PECB Exams app or paper-based at authorized test centers |
| Pre Condition: | Recommended: ISO 9001 Foundation knowledge or certification; no mandatory prerequisites, but experience in quality management is advised |
| Official Syllabus URL: | https://pecb.com/en/education-and-certification-for-individuals/iso-9001/iso-9001-lead-auditor |
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질문 # 221
XYZ Corporation employs 100 people, and during a Stage 1 certification audit, certain issues are identified with the Quality Management System (QMS). Which two options describe the circumstances in which you could raise a nonconformity against Clause 6.2 of ISO 9001:2015?
정답：B,C
설명：
* Understanding Clause 6.2 of ISO 9001:2015:Clause 6.2 (Quality Objectives and Planning to Achieve Them) specifies that organizations must:
* Establish measurable and relevant quality objectives consistent with the quality policy (Clause
6.2.1).
* Include objectives applicable to product/service conformity and customer satisfaction.
* Document these objectives and their planning as documented information (Clause 6.2.1 &
6.2.2).
* Plan how to achieve the objectives, including defining actions, resources, responsibilities, timelines, and methods for evaluation.
* Analysis of Options:
* A. Quality objectives are not being implemented by the organisation's personnel:Incorrect.
While implementation is critical, this relates more to operational aspects rather than the direct requirements of Clause 6.2. Implementation issues would typically raise concerns under Clause
9.1 (Performance Evaluation).
* B. The consultant has not interpreted ISO 9001 correctly:Incorrect. The consultant's interpretation of ISO 9001 is irrelevant in terms of Clause 6.2 compliance. The focus is on whether the organization aligns with the requirements, not the consultant's role.
* C. Establishing quality objectives did not include top management:Incorrect. While top management involvement is vital for QMS effectiveness (Clause 5.1), this is not a direct requirement of Clause 6.2. Top management alignment is implied but not explicitly mandated for establishing quality objectives.
* D. Quality objectives were not established in alignment with the organisation's quality policy:Correct. Clause 6.2.1 requires that quality objectives be consistent with the organization's quality policy, ensuring they reflect its purpose, strategic direction, and commitment to continual improvement. Misalignment would constitute a nonconformity.
* E. The organisation cannot afford to undertake quality objectives all at once:Incorrect.
Financial constraints are not directly addressed in Clause 6.2. The clause focuses on planning to achieve objectives, which includes defining the necessary resources but does not demand achieving all objectives simultaneously.
* F. Quality objectives are not maintained as documented information:Correct. Clause 6.2.1 specifically requires that quality objectives be maintained as documented information. Failure to document the objectives is a direct violation of this clause.
* Why Options D and F Are Correct:
* D: Misalignment between the quality objectives and the quality policy directly violates Clause
6.2.1, which mandates that objectives support the strategic direction of the organization.
* F: Lack of documentation for quality objectives breaches the requirement to maintain them as documented information under Clause 6.2.1.
* Relevant References:
* Clause 6.2.1: Establishing quality objectives aligned with the quality policy.
* Clause 6.2.2: Maintaining documented information for quality objectives and planning to achieve them.
* Clause 5.1.1: Top management's responsibility to ensure alignment between the QMS and strategic direction.
질문 # 222
What should the auditor document during the Stage 1 audit?
정답：C
설명：
Comprehensive and Detailed In-Depth Explanation:
Stage 1 Audit (ISO 9001:2015, Clause 9.2.2) is a documentation review to assess the readiness for a Stage 2 Audit. The auditor must document:
Observations that could lead to nonconformities, ensuring they are addressed before Stage 2.
Areas needing improvement, such as missing documented information or unclear process definitions.
While understanding the auditee's main processes is important, documenting interviews is not a requirement at Stage 1.
Reference:
ISO 9001:2015, Clause 9.2.2 (Internal Audit Reporting)
질문 # 223
What should the auditor document during the Stage 1 audit?
정답：C
설명：
Comprehensive and Detailed In-Depth Explanation:Stage 1 Audit (ISO 9001:2015, Clause 9.2.2) is a documentation review to assess the readiness for a Stage 2 Audit. The auditor must document:
* Observations that could lead to nonconformities, ensuring they are addressed before Stage 2.
* Areas needing improvement, such as missing documented information or unclear process definitions
.
While understanding the auditee's main processes is important, documenting interviews is not a requirement at Stage 1.
질문 # 224
Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry.
The Quality Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it at the moment. You learn that the shop managers were told to dismiss most of the claims on the basis of the poor quality of the laundered materials.
On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.
When reviewing the customer complaint file, you find that the organisation is facing a legal dispute with a customer over damage to an expensive cashmere coat.
Select the best option for how this should be handled by the Quality Management System.
정답：B
설명：
According to the ISO 9001:2015 standard, clause 10.2 requires organizations to review nonconformities, including any arising from customer complaints, and to take appropriate actions to determine the cause, implement corrections and preventive actions, and verify their effectiveness. The organization must also monitor the effectiveness of the actions taken and make changes if necessary.
In this scenario, the auditee is facing a legal dispute with a customer over damage to an expensive cashmere coat. This is a nonconformity that arises from customer complaint and has a significant impact on customer satisfaction and reputation. Therefore, clause 10.2 applies to this situation.
The best option for how this should be handled by the Quality Management System is B.
B means that the organization should report the situation to the customer with suggested remedial action. This option follows the principle of transparency and accountability, as well as respecting the customer's rights and expectations. The organization should also investigate the root cause of the damage and prevent it from happening again in other shops or products.
The other options are not appropriate because:
A means that the organization should settle the court case by negotiation with the customer. This option may not be feasible or satisfactory for both parties, especially if there is a large amount of compensation involved or if there are legal implications for other customers.
C means that the organization should make an offer to replace the coat with a new one. This option may not be sufficient or acceptable for both parties, especially if there is evidence of negligence or poor quality on behalf of the organization.
D means that the organization should give an explanation to the customer of what went wrong. This option may not be enough or convincing for both parties, especially if there is no evidence of negligence or poor quality on behalf of the organization.
질문 # 225
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oll and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. You, as one of the auditors, find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality Manager explains that the Managing Director authorised release of the anodes to avoid late delivery as penalties would be imposed. The customer was not informed since the tests very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
Which of the following options for the best description of the nonconformity?
정답：C
설명：
Clause Reference - ISO 9001:2015 Clause 8.6 (Release of Products and Services):
ISO 9001 requires that products and services are not released to the customer until:
All planned verification activities have been completed.
Acceptance criteria have been met.
Any necessary approvals have been obtained.
In this scenario:
The sacrificial anodes for Project DK were shipped before the galvanic efficiency test results were analyzed.
This constitutes a nonconformity against Clause 8.6 because the products were released without completing the required tests.
Option Analysis:
A). A retrospective concession was not sought from the customer once the test results had been approved by the Quality Manager:Incorrect. While obtaining a concession might mitigate the situation, the nonconformity pertains to the process failure of releasing the products without completing required tests, not the absence of a concession.
B). Release of the product without acceptable test results has been accepted by the customer for Project DK:
Incorrect. The customer was not informed before the release, and there is no indication that this was accepted beforehand. Furthermore, ISO 9001 requires planned processes to be followed, regardless of later acceptance.
C). Products for Project DK have been released before product approval through the quality control process:
Correct. This description accurately reflects the nonconformity. The quality control process required test results to be analyzed and verified before release, which did not happen.
D). The untested product was not recalled until the galvanic efficiency of the anodes was verified:Incorrect.
The issue is not about recalling the product but about releasing it without completing the required tests.
Recalling the product is not mentioned in the scenario.
Why C is Correct:
The nonconformity is a clear breach of Clause 8.6, where the products were released without meeting the planned verification requirements.
This demonstrates a failure in adhering to quality control processes, which is a critical aspect of ISO 9001 compliance.
Key ISO 9001 Reference:
Clause 8.6: Products and services shall not be released to the customer until all planned activities (e.g., testing) have been satisfactorily completed, or the customer has approved the release with knowledge of deviations.
질문 # 226
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